Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

NCT02419976 | Terminated Results FDA Device

• 1 other identifier: 14-009226
• Study Type: interventional
• Target: 879
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.

Conditions

Fasting

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile

  Exhaled Volatile Organic Compounds (VOCs) were collected by subject's breathing into a non-invasive breath analyzer (Aeonose) for 5 minutes by which through pattern recognition electronic changes can be identified in exhaled volatile organic compounds interfacing with an electronic sensor that creates an electronic signature, or smell-print that distinguishes the fasting and non-fasting states. The effectiveness of the Aeonose in distinguishing subjects in a fasting versus non-fasting state is represented by the device's sensitivity and specificity (ability to positively identify subjects who are in a fasting state versus non-fasting state).

  breath analysis obtained (approximately 10 minutes procedure)

Study Arms (1)

Breath Analysis

EXPERIMENTAL

Individuals consenting to participation of this study will be asked to provide a breath analysis using the Aeonose. Following their scheduled standard of care endoscopic procedure the patient will repeat the breath analysis.

Other: a breath analysis using the Aeonose; Device: Aeonose

Interventions

a breath analysis using the Aeonose OTHER

using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 5 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure. Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure.

Also known as: Enose

Breath Analysis

Aeonose DEVICE

Breath Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy
• Willing and able to consent to research protocol
• Fasting as required per routine instruction for upper endoscopy
• Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on
• Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy

You may not qualify if:

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• Non-fasting per protocol, or known to have had food or drink outside of routine protocol
• \< 18 years of age
• Unable or unwilling to consent to research protocol
• Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)
• Unable to consume refreshment post procedurally
• Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Limitations and Caveats

This study was terminated early due to a loss of funding and all activities in the Netherlands being terminated as of June 20th 2024.

Results Point of Contact

• Title: Kevin Buller
• Organization: Mayo Clinic

Buller.Kevin@mayo.edu

507-255-5476

Study Officials

• Cadman Leggett, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 17, 2015
• Study Start: February 1, 2015
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)